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Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass

Dielectric Property Test Compared With Frozen Pathological Section in the Rapid Diagnosis of Lung Nodules/Mass: a Diagnostic Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03339479
Enrollment
502
Registered
2017-11-13
Start date
2017-05-25
Completion date
2020-05-24
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Mass, Lung Nodules

Keywords

dielectric property, lung nodules, differential diagnosis, frozen pathological examination

Brief summary

Patients with lung nodules/mass found by CT (computed tomography) or PET (positron emission tomography) who agree to receive lung resection are arranged to test the dielectric property before receiving the frozen pathological examination. And the final pathological results are recognized as the standard diagnosis. Then the sensitivity and specificity of the dielectric property test will be evaluated comparing with the frozen pathological examination.

Interventions

DIAGNOSTIC_TESTdielectric property test

Test the dielectric property of resected lung nodules/mass through a touching probe after the lung tissue with nodules/mass has been resected and cut open, which usually takes only 1-5 minutes.

DIAGNOSTIC_TESTfrozen pathological examination

And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.

DIAGNOSTIC_TESTfinal pathological examination

All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

self-control method

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with lung nodules/mass found by CT or PET who agree to receive lung resection; * Diameter of the lung nodule/mass is longer than 8 millimeters; * More than 50% of the lung nodule/mass is solid component by image examination; * Diameter of the solid component is longer than 5 millimeters by intraoperative exploration.

Exclusion criteria

* Cutting open the resected nodule/mass will interfered with the pathological examination; * Diameter of the solid component is shorter than 5 millimeters by intraoperative cutting open; * Cutting open the lung nodule/mass will cause great damage to the patient, such as inducing allergic shock.

Design outcomes

Primary

MeasureTime frameDescription
sensitivity of dielectric property test in diagnosing lung nodules/masses3-5 yearstrue positive rate in diagnosing lung nodules/masses
specificity of dielectric property test in diagnosing lung nodules/masses3-5 yearstrue negative rate in diagnosing lung nodules/masses

Countries

China

Contacts

Primary ContactDi Lu, MD,PhD
david_lu1989@163.com86+13268379321
Backup ContactSiyang Feng, MD
fengsy89@163.com86+13570930671

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026